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ID
Source
Brief title
Health condition
N/A
Sponsors and support
Intervention
Outcome measures
Primary outcome
Producing 3D replicas of the pelvis, the uterus including placenta, amniotic fluid and child, the pelvic floor and the birth canal of the pregnant woman by using already made and existing MRIs.
Secondary outcome
The 3D replicas should help in the evaluation how we might design a procedure and device for the AW that will allow medical professionals to successfully transfer a premature baby from the vaginal birth canal into the artificial uterus without causing unnecessary physical or psychological damage.
Background summary
To improve the outcomes for extreme preterm infants, the Perinatal Life Support (PLS) consortium is developing a medical device - an artificial womb (AW) - that supports the growth of this extremely premature group better and safer outside the uterus. Rather than exposing the preterm child to the stressful treatments of the NICU, the AW retains the liquid environment of the natural uterus. In order to ensure that the transfer of the premature child runs as smoothly as possible, a device with artificial amniotic fluid is developed to accommodate the premature child during a vaginal birth. The child will be placed in the AW from this “collection bag”. In order to develop a device that optimally matches the birth canal of the mother during delivery, we want to produce realistic replicas of the uterus, placenta, fetus in the uterus, pelvic floor and birth canal. In this retrospective study we will be using existing MRI images of pregnant women, in order to model these anatomical parts in 3D software.
Study objective
This is a retrospective study to make use of existing MRIs made from pregnant women who suspected a complication after bariatric surgery in pregnancy to make 3D replicas.
Study design
The patients will be contacted by the coordinating investigator and in case of consent these patients will be sent a PIF.
Intervention
No interventions, study is retrospective.
Inclusion criteria
- MRI is made at an amenorrhea period of 20-30 weeks.
- Pregnant patients suspected of having a complication after bariatric surgery and who have had an MRI.
Exclusion criteria
- Major anatomical abnormalities of the fetus and birth canal.
- Placenta previa.
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL8681 |
| Other | METC MMC : TBD |